June 13, 2009FDA Requests Labeling Change for Leukotriene Modifiers FDA Requests Labeling Change for Leukotriene Modifiers
The U.S. Food and Drug Administration today provided further updated safety information on a class of asthma drugs known as leukotriene modifiers. FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling) regarding neuropsychiatric events (behavior, mood changes) that have been reported in some persons taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). Source: www.fda.gov FDA Warns About Serious Liver Injury Associated With Anti-Thyroid Drug The U.S. Food and Drug Administration today warned health care professionals about the risk of serious liver injury associated with the use of the anti-thyroid drug propylthiouracil (PTU) for the treatment of Graves’ disease. Source: www.fda.gov FDA Approves Injectable Form of Ibuprofen The U.S. Food and Drug Administration today approved Caldolor, the first injectable dosage form of the common pain medication ibuprofen, to treat pain and fever. Source: www.fda.gov FDA Issues Public Health Advisory Regarding Levemir Insulin The U.S. Food and Drug Administration has learned that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. have reappeared and are being sold in the U.S. market. Three lots or a total of 129,000 vials of this product were stolen in all. These stolen insulin vials may not have been stored and handled properly and may be dangerous for patients to use. Source: www.fda.gov U.S. Attorney News Release: Robert McFadden Palms Springs Attorney Sentenced for Prescription Drug Diversion This press release is not being maintained on the FDA site. View the PDF version of this press announcement now. Source: www.fda.gov FDA Forms Transparency Task Force The U.S. Food and Drug Administration (FDA) today announced the formation of a task force to develop recommendations for enhancing the transparency of the agency’s operations and decision-making process. Source: www.fda.gov U.S. Attorney News Release: California Man Sentenced for Prescription Drug Diversion U.S. Attorney News Release: California Man Sentenced for Prescription Drug Diversion
CONCORD, NEW HAMPSHIRE: Thomas Lavery, of Irvine, CA, was sentenced to 52 months of incarceration to be followed by three years of supervised release for illegally distributing large quantities of Serostim, an HIV drug, which were illegally purchased from illegitimate sources and then illegally sold to wholesale distributors in various parts of the country, using falsified paperwork. Judge McAuliffe also entered an order of forfeiture against Lavery for the sum of $1,009,460. Source: www.fda.gov New Labeling Required for OTC Pain and Fever Medicines On April 28, 2009, FDA issued a final rule that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling Source: www.fda.gov U.S. Attorney News Release: Robert McFadden Palms Springs Attorney Sentenced for Prescription Drug Diversion This press release is not being maintained on the FDA site. View the PDF version of this press announcement now. Source: www.fda.gov FDA Alerts Consumers to Recall of Water-Based Face Paints The Food and Drug Administration is advising consumers to stop using certain cosmetic “Face Paint” items labeled as distributed by Oriental Trading Co., Omaha, Neb., due to adverse event reports of skin reactions in children. These items were distributed nationwide. Source: www.fda.gov June 12, 2009Recalls and Safety Alerts: Zoll AED Plus Defibrillator Recalled Recalls and Safety Alerts: Zoll AED Plus Defibrillator Recalled
The device company Zoll Medical Corporation is recalling AED Plus Defibrillators that were manufactured between May 2004 and February 2009. Some of the batteries in these devices may not work properly, and the original self-test software cannot adeq... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Recall of Medtronic Ventricular Snap Shunt Catheters Medtronic Neurologic Technologies has recalled the company's Bioglide Ventricular Snap Shunt Catheter, which is a component of a shunt system that is used to treat hydrocephalus. The catheters may become detached from the snap base assembly, and tha... Source: www.accessdata.fda.gov Tri-State Hospital Supply Corporation, Centurion Brand Trays and Kits Tri-State Hospital Supply Corporation, Centurion Brand Trays and Kits Source: www.fda.gov Medtronic Neurologic Technologies, Innervision Snap Shunt Ventricular Catheter, BioGlide and Snap Shunt Ventricular Catheter, BioGlide Source: www.fda.gov Dietary Supplements Distributed by Universal ABC Beauty Supply International, Inc. Dietary Supplements Distributed by Universal ABC Beauty Supply International, Inc.
Source: www.fda.gov Biosite brand Triage Cardiac Panel Use of affected lots of the Triage Cardiac Panel may lead to false negative results, possibly resulting in missed or incorrect diagnosis. Source: www.fda.gov Influend Cough and Cold Products Influend Cough and Cold Products Source: www.fda.gov Ceftriaxone (marketed as Rocephin and generics) Ceftriaxone (marketed as Rocephin and generics) Source: www.fda.gov Medtronic Neurologic Technologies, Innervision Snap Shunt Ventricular Catheter, BioGlide and Snap Shunt Ventricular Catheter, BioGlide Source: www.fda.gov Testosterone gel products (AndroGel 1% and Testim 1% ) Testosterone gel products (AndroGel 1% and Testim 1% )
Boxed warning required to inform users of risk of unintended secondary exposure of children to testosterone. Source: www.fda.gov Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR) FDA provided healthcare professionals with updated information on the original March 2008 early communication and January 2009 follow-up communcation about the ongoing safety review for the Leukotriene inhibitors, montelukast, zafirlukast and zileuton. Neuropsychiatric events have been reported in some patients taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling). The reported neuropsychiatric events include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor. Source: www.fda.gov FDA and International Consortium Report New Data on Drug-Induced Liver Injury The U.S. Food and Drug Administration and the International Serious Adverse Event Consortium (SAEC) today announced important strides in the understanding of the genetic basis for drug-induced liver injury. Source: www.fda.gov Dietary Supplements Distributed by Universal ABC Beauty Supply International, Inc. Source: www.fda.gov FDA Approves Besivance to Treat Bacterial Conjunctivitis The U.S. Food and Drug Administration today approved Besivance (besifloxacin ophthalmic suspension 0.6 percent) for the treatment of bacterial conjunctivitis (non-viral), a contagious condition marked by irritation of the eyes and a discharge from the mucous membranes. Source: www.fda.gov Simponi (golimumab) Risk of serious fungal infections associated with TNF-α blockers, including Simponi (golimumab). Posted 05/28/2009 Source: www.fda.gov FDA Approves Injectable Form of Ibuprofen The U.S. Food and Drug Administration today approved Caldolor, the first injectable dosage form of the common pain medication ibuprofen, to treat pain and fever. Source: www.fda.gov FDA Alerts Patients to Medtronic Pacemaker Recall The U.S. Food and Drug Administration is alerting patients to the Class I recall of certain Medtronic Kappa and Sigma pacemakers. These devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery. Source: www.fda.gov November 2008 MedWatch November 2008 Drug Safety Labeling Changes Source: www.fda.gov October 2008 MedWatch October 2008 Drug Safety Labeling Changes Source: www.fda.gov June 11, 2009November 2008 November 2008
MedWatch November 2008 Drug Safety Labeling Changes Source: www.fda.gov Warning on Hydroxycut Products FDA is warning consumers to stop using Hydroxycut products because of serious health risks. One death due to liver failure has been reported to the agency. Source: www.fda.gov Antiepileptic Drugs Source: www.fda.gov Safety Concerns About Testosterone Gel Side effects in children prompt additional warnings on testosterone gel products for adults. Source: www.fda.gov Are You Taking Medication as Prescribed? Strategies for improving medication adherence. Source: www.fda.gov January 2009 January 2009 Drug Safety Labeling Changes Source: www.fda.gov FDA Warns About Raw Alfalfa Sprouts On April 26, 2009, FDA and CDC recommended that consumers not eat raw alfalfa sprouts until further notice because the product has been linked to Salmonella contamination Source: www.fda.gov Safety Concerns and Labeling Changes for Psoriasis Drug Raptiva FDA has received reports of serious infections leading to hospitalizations and deaths in people who use Raptiva Source: www.fda.gov Recalls and Safety Alerts: Recalls of Digoxin and Propafenone Tablets Recalls and Safety Alerts: Recalls of Digoxin and Propafenone Tablets
FDA has posted information about two cardiac drugs that were recently recalled because of variability in the size of the tablets: ? Caraco Pharmaceutical Laboratories, a manufacturer of generic pharmaceuticals, recalled some of their digoxin table... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Recall of Medtronic Ventricular Snap Shunt Catheters Recalls and Safety Alerts: Recall of Medtronic Ventricular Snap Shunt Catheters
Medtronic Neurologic Technologies has recalled the company's Bioglide Ventricular Snap Shunt Catheter, which is a component of a shunt system that is used to treat hydrocephalus. The catheters may become detached from the snap base assembly, and tha... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Recalls of Digoxin and Propafenone Tablets FDA has posted information about two cardiac drugs that were recently recalled because of variability in the size of the tablets: ? Caraco Pharmaceutical Laboratories, a manufacturer of generic pharmaceuticals, recalled some of their digoxin table... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Raptiva Withdrawn from the Market Genentech is conducting a phased market withdrawal of the psoriasis drug Raptiva (efalizumab). The company is doing this because taking the drug carries the risk of developing progressive multifocal leukoencephalopathy (PML). PML, which is caused by... Source: www.accessdata.fda.gov FDA Consumer Corner: Don?t Overdo It with Acetaminophen If you woke up with a headache this morning, you may have reached for an over-the-counter pain reliever. Millions of people do that everyday, and there's usually no problem. Over-the-counter pain relievers are effective for treating minor aches and... Source: www.accessdata.fda.gov New from FDA: Campaign on Using Methadone Safely FDA and the Substance Abuse and Mental Health Services Administration (SAMHSA) have launched a campaign to increase awareness about the risks associated with using methadone and how to minimize them. Methadone has long been used to treat drug addict... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Zoll AED Plus Defibrillator Recalled The device company Zoll Medical Corporation is recalling AED Plus Defibrillators that were manufactured between May 2004 and February 2009. Some of the batteries in these devices may not work properly, and the original self-test software cannot adeq... Source: www.accessdata.fda.gov June 10, 2009Consumers Warned Not to Use Clarcon Skin Products Consumers Warned Not to Use Clarcon Skin Products
The U.S. Food and Drug Administration announced today that Clarcon Biological Chemistry Laboratory Inc. of Roy, Utah, is voluntarily recalling some skin sanitizers and skin protectants marketed under several different brand names because of high levels of disease-causing bacteria found in the product during a recent inspection. The FDA is warning consumers to not use any Clarcon products. Source: www.fda.gov Are You Taking Medication as Prescribed? Are You Taking Medication as Prescribed?
Strategies for improving medication adherence. Source: www.fda.gov Giving Medication to Children The director of FDA's Office of Pediatric Therapeutics discusses what parents should know about medication use in children. Source: www.fda.gov FDA's MedWatch Safety Alerts: June 2009 FDA has issued recent safety alerts on these medical products. Source: www.fda.gov FDA Consumer Corner: Don?t Overdo It with Acetaminophen FDA Consumer Corner: Don?t Overdo It with Acetaminophen
If you woke up with a headache this morning, you may have reached for an over-the-counter pain reliever. Millions of people do that everyday, and there's usually no problem. Over-the-counter pain relievers are effective for treating minor aches and... Source: www.accessdata.fda.gov Insulin Pens: Risk of Transmission of Blood-borne Pathogens from Shared Use Source: www.fda.gov Recalls and Safety Alerts: Recall of Medtronic Ventricular Snap Shunt Catheters Medtronic Neurologic Technologies has recalled the company's Bioglide Ventricular Snap Shunt Catheter, which is a component of a shunt system that is used to treat hydrocephalus. The catheters may become detached from the snap base assembly, and tha... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Raptiva Withdrawn from the Market Genentech is conducting a phased market withdrawal of the psoriasis drug Raptiva (efalizumab). The company is doing this because taking the drug carries the risk of developing progressive multifocal leukoencephalopathy (PML). PML, which is caused by... Source: www.accessdata.fda.gov Dietary Supplements Distributed by Universal ABC Beauty Supply International, Inc. Source: www.fda.gov June 9, 2009January 2009 January 2009
January 2009 Drug Safety Labeling Changes Source: www.fda.gov Biosite brand Triage Cardiac Panel Use of affected lots of the Triage Cardiac Panel may lead to false negative results, possibly resulting in missed or incorrect diagnosis. Source: www.fda.gov Digoxin, USP 0.125 mg, Digoxin, USP 0.25 mg (Caraco brand) Source: www.fda.gov Influend Cough and Cold Products Influend Cough and Cold Products Source: www.fda.gov FDA Consumer Corner: Don?t Overdo It with Acetaminophen If you woke up with a headache this morning, you may have reached for an over-the-counter pain reliever. Millions of people do that everyday, and there's usually no problem. Over-the-counter pain relievers are effective for treating minor aches and... Source: www.accessdata.fda.gov Propylthiouracil Propylthiouracil (PTU)-Induced Liver Failure Source: www.fda.gov Zencore Plus Source: www.fda.gov Antiepileptic Drugs Source: www.fda.gov New from FDA: Campaign on Using Methadone Safely FDA and the Substance Abuse and Mental Health Services Administration (SAMHSA) have launched a campaign to increase awareness about the risks associated with using methadone and how to minimize them. Methadone has long been used to treat drug addict... Source: www.accessdata.fda.gov FDA Warns Consumers Not to Use Skin Products Made by Clarcon Due to Bacterial Contamination Risk FDA Warns Consumers Not to Use Skin Products Made by Clarcon Due to Bacterial Contamination Risk
The U.S. Food and Drug Administration announced today that Clarcon Biological Chemistry Laboratory Inc. of Roy, Utah, is voluntarily recalling some skin sanitizers and skin protectants marketed under several different brand names because of high levels of disease-causing bacteria found in the product during a recent inspection. The FDA is warning consumers to not use any Clarcon products. Source: www.fda.gov FDA Approves New Total Ankle Replacement System The U.S. Food and Drug Administration today approved a total ankle replacement system for arthritic or deformed ankles that may preserve some range of motion in the joint. Source: www.fda.gov Biosite brand Triage Cardiac Panel Biosite brand Triage Cardiac Panel
Use of affected lots of the Triage Cardiac Panel may lead to false negative results, possibly resulting in missed or incorrect diagnosis. Source: www.fda.gov Antiepileptic Drugs Source: www.fda.gov Medtronic Neurologic Technologies, Innervision Snap Shunt Ventricular Catheter, BioGlide and Snap Shunt Ventricular Catheter, BioGlide Source: www.fda.gov November 2008 MedWatch November 2008 Drug Safety Labeling Changes Source: www.fda.gov Fun Express Water-based Face Paints for Children UPDATE - Fun Express expanded its recall of face paint items to include two additional face paint colors, 85/2338 (White face paint) and 85/2339 (Yellow face paint) Source: www.fda.gov January 2009 January 2009 Drug Safety Labeling Changes Source: www.fda.gov New from FDA: Campaign on Using Methadone Safely FDA and the Substance Abuse and Mental Health Services Administration (SAMHSA) have launched a campaign to increase awareness about the risks associated with using methadone and how to minimize them. Methadone has long been used to treat drug addict... Source: www.accessdata.fda.gov Propylthiouracil Propylthiouracil (PTU)-Induced Liver Failure Source: www.fda.gov Tri-State Hospital Supply Corporation, Centurion Brand Trays and Kits Tri-State Hospital Supply Corporation, Centurion Brand Trays and Kits Source: www.fda.gov June 8, 2009FDA Approves Pancreatic Enzyme Replacement Product for Marketing in United States FDA Approves Pancreatic Enzyme Replacement Product for Marketing in United States
The U.S. Food and Drug Administration announced today that it has approved Creon (pancrelipase), a pancreatic enzyme replacement product designed to help patients with cystic fibrosis and others with exocrine pancreatic insufficiency (EPI) digest and absorb nutrients from foods. Creon is the first FDA-approved delayed-release pancreatic enzyme replacement product to be marketed in the United States as a result of the agency's unapproved drugs initiative. Source: www.fda.gov FDA Warns Consumers to Stop Using Hydroxycut Products The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market. Source: www.fda.gov FDA Approves New Total Ankle Replacement System The U.S. Food and Drug Administration today approved a total ankle replacement system for arthritic or deformed ankles that may preserve some range of motion in the joint. Source: www.fda.gov Safety Concerns and Labeling Changes for Psoriasis Drug Raptiva FDA has received reports of serious infections leading to hospitalizations and deaths in people who use Raptiva Source: www.fda.gov FDA Warns About Serious Liver Injury Associated With Anti-Thyroid Drug The U.S. Food and Drug Administration today warned health care professionals about the risk of serious liver injury associated with the use of the anti-thyroid drug propylthiouracil (PTU) for the treatment of Graves’ disease. Source: www.fda.gov Warning on Hydroxycut Products FDA is warning consumers to stop using Hydroxycut products because of serious health risks. One death due to liver failure has been reported to the agency. Source: www.fda.gov Ceftriaxone (marketed as Rocephin and generics) Ceftriaxone (marketed as Rocephin and generics) Source: www.fda.gov DOJ News Release: President of Company That Illegally Imported Catfish Sentenced to More Than Five Years in Federal Prison A Virginia man has been sentenced to 63 months in federal prison for participating in a conspiracy that led to more than 10 million pounds of frozen catfish being imported from Vietnam, but fraudulently labeled and sold in the United States as sole, grouper and other species, the Justice Department announced. This sentence is one of the longest imposed by a federal judge for falsely labeling seafood. Source: www.fda.gov FDA Oncologist Receives Top Award for Contributions to Cancer Research Richard Pazdur, M.D., a noted oncologist at the U.S. Food and Drug Administration, is being recognized today by the world's largest cancer professional society. Source: www.fda.gov FDA Alerts Consumers to Recall of Water-Based Face Paints The Food and Drug Administration is advising consumers to stop using certain cosmetic “Face Paint” items labeled as distributed by Oriental Trading Co., Omaha, Neb., due to adverse event reports of skin reactions in children. These items were distributed nationwide. Source: www.fda.gov Influend Cough and Cold Products Influend Cough and Cold Products
Influend Cough and Cold Products Source: www.fda.gov Welch Allyn AED 10 and and MRL JumpStart Defibrillators Source: www.fda.gov Insulin Pens: Risk of Transmission of Blood-borne Pathogens from Shared Use Source: www.fda.gov FDA Approves New Total Ankle Replacement System The U.S. Food and Drug Administration today approved a total ankle replacement system for arthritic or deformed ankles that may preserve some range of motion in the joint. Source: www.fda.gov FDA Warns About Serious Liver Injury Associated With Anti-Thyroid Drug The U.S. Food and Drug Administration today warned health care professionals about the risk of serious liver injury associated with the use of the anti-thyroid drug propylthiouracil (PTU) for the treatment of Graves’ disease. Source: www.fda.gov Ceftriaxone (marketed as Rocephin and generics) Ceftriaxone (marketed as Rocephin and generics) Source: www.fda.gov H1N1 Flu: FDA Responds Quickly to Protect the Public's Health H1N1 Flu: FDA Responds Quickly to Protect the Public's Health
FDA is addressing the H1N1 flu outbreak with a team-based incident management approach Source: www.fda.gov The Scoop on Whole Grains What are whole grains and how much should you eat? Source: www.fda.gov FDA 101: Clinical Trials and Institutional Review Boards Clinical trials test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. Source: www.fda.gov Safety Concerns About Testosterone Gel Side effects in children prompt additional warnings on testosterone gel products for adults. Source: www.fda.gov FDA's MedWatch Safety Alerts: April 2009 FDA's MedWatch Safety Alerts: April 2009
Home Page for the Food and Drug Administration (FDA): Consumer Health Information Source: www.fda.gov On the Road Again: FDA's Mobile Laboratories Mobile laboratories help FDA quickly test food and drugs for contaminants. Source: www.fda.gov Safety Concerns About Testosterone Gel Side effects in children prompt additional warnings on testosterone gel products for adults. Source: www.fda.gov H1N1 Flu: FDA Responds Quickly to Protect the Public's Health FDA is addressing the H1N1 flu outbreak with a team-based incident management approach Source: www.fda.gov Insulin Pens are Not for Sharing Insulin pens should not be used on multiple patients. Source: www.fda.gov Itching for Allergy Relief? Strategies for treating seasonal allergies Source: www.fda.gov Warning on Hydroxycut Products FDA is warning consumers to stop using Hydroxycut products because of serious health risks. One death due to liver failure has been reported to the agency. Source: www.fda.gov More Weight Loss Products Added to Consumer Alert FDA has alerted consumers not to buy or use more than 25 weight-loss products Source: www.fda.gov The Scoop on Whole Grains What are whole grains and how much should you eat? Source: www.fda.gov Recalls and Safety Alerts: Recall of Medtronic Ventricular Snap Shunt Catheters Recalls and Safety Alerts: Recall of Medtronic Ventricular Snap Shunt Catheters
Medtronic Neurologic Technologies has recalled the company's Bioglide Ventricular Snap Shunt Catheter, which is a component of a shunt system that is used to treat hydrocephalus. The catheters may become detached from the snap base assembly, and tha... Source: www.accessdata.fda.gov FDA Consumer Corner: Don?t Overdo It with Acetaminophen If you woke up with a headache this morning, you may have reached for an over-the-counter pain reliever. Millions of people do that everyday, and there's usually no problem. Over-the-counter pain relievers are effective for treating minor aches and... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Raptiva Withdrawn from the Market Genentech is conducting a phased market withdrawal of the psoriasis drug Raptiva (efalizumab). The company is doing this because taking the drug carries the risk of developing progressive multifocal leukoencephalopathy (PML). PML, which is caused by... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Recalls of Digoxin and Propafenone Tablets FDA has posted information about two cardiac drugs that were recently recalled because of variability in the size of the tablets: ? Caraco Pharmaceutical Laboratories, a manufacturer of generic pharmaceuticals, recalled some of their digoxin table... Source: www.accessdata.fda.gov June 7, 2009Recalls and Safety Alerts: Recalls of Digoxin and Propafenone Tablets Recalls and Safety Alerts: Recalls of Digoxin and Propafenone Tablets
FDA has posted information about two cardiac drugs that were recently recalled because of variability in the size of the tablets: ? Caraco Pharmaceutical Laboratories, a manufacturer of generic pharmaceuticals, recalled some of their digoxin table... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Zoll AED Plus Defibrillator Recalled The device company Zoll Medical Corporation is recalling AED Plus Defibrillators that were manufactured between May 2004 and February 2009. Some of the batteries in these devices may not work properly, and the original self-test software cannot adeq... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Raptiva Withdrawn from the Market Genentech is conducting a phased market withdrawal of the psoriasis drug Raptiva (efalizumab). The company is doing this because taking the drug carries the risk of developing progressive multifocal leukoencephalopathy (PML). PML, which is caused by... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Recall of Zencore Plus Bodee LLC is recalling its supplement product called Zencore Plus after FDA laboratory analysis showed that the product contains benzamidenafil. This is a newly discovered PDE5 inhibitor that is likely to have the same pharmacologic properties as si... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Recall of Medtronic Ventricular Snap Shunt Catheters Medtronic Neurologic Technologies has recalled the company's Bioglide Ventricular Snap Shunt Catheter, which is a component of a shunt system that is used to treat hydrocephalus. The catheters may become detached from the snap base assembly, and tha... Source: www.accessdata.fda.gov New from FDA: Campaign on Using Methadone Safely FDA and the Substance Abuse and Mental Health Services Administration (SAMHSA) have launched a campaign to increase awareness about the risks associated with using methadone and how to minimize them. Methadone has long been used to treat drug addict... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Preventing Misconnection Errors ? Medical Device Safety Calendar FDA has received many reports of patient injuries and deaths when different device delivery systems are mistakenly connected to each other. These errors are often facilitated by fittings called Luer Connectors, which allow different systems to be ea... Source: www.accessdata.fda.gov Warning on Hydroxycut Products Warning on Hydroxycut Products
FDA is warning consumers to stop using Hydroxycut products because of serious health risks. One death due to liver failure has been reported to the agency. Source: www.fda.gov New from FDA: Campaign on Using Methadone Safely FDA and the Substance Abuse and Mental Health Services Administration (SAMHSA) have launched a campaign to increase awareness about the risks associated with using methadone and how to minimize them. Methadone has long been used to treat drug addict... Source: www.accessdata.fda.gov Itching for Allergy Relief? Strategies for treating seasonal allergies Source: www.fda.gov FDA Promotes Openness and Transparency to Public FDA is working to make useful information about FDA activities and decision making more readily available to the public. Source: www.fda.gov The Scoop on Whole Grains What are whole grains and how much should you eat? Source: www.fda.gov New Labeling Required for OTC Pain and Fever Medicines On April 28, 2009, FDA issued a final rule that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling Source: www.fda.gov More Weight Loss Products Added to Consumer Alert FDA has alerted consumers not to buy or use more than 25 weight-loss products Source: www.fda.gov Recalls and Safety Alerts: Recall of Medtronic Ventricular Snap Shunt Catheters Medtronic Neurologic Technologies has recalled the company's Bioglide Ventricular Snap Shunt Catheter, which is a component of a shunt system that is used to treat hydrocephalus. The catheters may become detached from the snap base assembly, and tha... Source: www.accessdata.fda.gov FDA 101: Clinical Trials and Institutional Review Boards Clinical trials test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. Source: www.fda.gov Insulin Pens are Not for Sharing Insulin pens should not be used on multiple patients. Source: www.fda.gov |
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